Wrongdoing Pays for Drugmaker as J & J Wraps up Risperdal Probe
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$2.2 billion. That is the amount the Johnson & Johnson (J&J) has agreed to set aside to settle a government probe and lawsuits involving the illegal marketing of its Risperdal antipsychotic drug. That would be just short of the record $2.3 billion Pfizer had to pay for the off-label promotions of painkiller Bextra in 2009.
J&J is accused of stepping over the line with its Risperdal marketing as well as the aggressive marketing of Natrecor for heart failure and another antipsychotic, Invega.
The federal probe uncovered that J&J was involved in a kickback plan with nursing home Omnicare to sell Risperdal for the elderly population suffering from dementia and anxiety, for which it is not prescribed, while downplaying the risks of diabetes and weight gain from patients and physicians. Even though J&J agreed to pay an $85 million fine in the Natrecor case, that did not release it from the civil suit.
Justice Department lawyers are attempting to get the new J&J CEO, Alex Gorsky, to testify about the Omnicare kickback charges. Omnicare has already paid $98 million to settle the civil claims it faced without admitting liability. Gorsky was president of the Janssen unit which oversaw the marketing and kickbacks to Omnicare at the time, but Pharmalot reports that this deal may mean that Gorsky would avoid being deposed.
In making the settlement J&J would agree to plead guilty to a misdemeanor charge and pay a criminal penalty of up to $600 million, though it is unclear whether J&J or one of its divisions would be charged criminally. The rest of the money resolves whistleblower claims and pays claims from some states to be reimbursed for the drugs it covered even though they were being used off-label.
In the case of Risperdal, the atypical antipsychotic was approved in1993 for psychotic disorders such as schizophrenia. But the J&J unit, Janssen, promoted it for use in patients suffering from dementia, anxiety, bipolar disorders, and other uses. Nursing home patients were kept quiet on a steady diet of Risperdal and the taxpayers were covering the cost, even though the use of Risperdal had not been studied in that population.
J&J is not alone in its reckless and questionable behavior. Lilly paid more than $1.7 billion, reports Bloomberg, to settle federal and state investigation over its atypical antipsychotic Zyprexa, while AstraZeneca has paid almost $590 million. Pfizer is on the hook $301 million over its bi-polar drug, Geodon.
And when the government pays for these drugs, the states usually ask to be reimbursed. Bloomberg reports that J&J faces a total of $1.8 billion in fines in Arkansas, Louisiana and South Carolina while Texas settled for $158 million.
The Justice Department has been investigating J&J since 2004 for its marketing practices of Risperdal but that doesn’t seem to deter the practice.
The final figures may tell that story. The marketing for Risperdal was such a success it was once the best-selling drug for J&J. The $2.2 billion amounts to less than 10 percent of the Risperdal sales or $24 billion since 2003. The company lost the patent protection in 2007.